Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01233648
First received: November 2, 2010
Last updated: November 21, 2011
Last verified: November 2011

November 2, 2010
November 21, 2011
June 2006
November 2015   (final data collection date for primary outcome measure)
AF burden [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01233648 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)
Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. One group will have their heart rate controlled by the ICD and AVN ablation alone and the second group will be treated with the ICD, AVN ablation and standard medical therapies to restore the heart's normal rhythm. The study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and AF, resulting in a better quality of life.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Atrial Fibrillation
  • Other: rate control via CRT-D and AVN ablation
    rate control
  • Other: rhythm control via pharmacologic, electrical or ablative therapies
    rhythm control
  • Active Comparator: AF
    Intervention: Other: rate control via CRT-D and AVN ablation
  • Active Comparator: SR
    Intervention: Other: rhythm control via pharmacologic, electrical or ablative therapies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
December 2016
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
  • In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
  • Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
  • Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
  • Not taking or able to be taken off all type I/III antiarrhythmic medications.
  • Taking Coumadin so as to maintain an INR of between 2 and 3.
  • A Class I or IIa ICD indication
  • NYHA Class III/IV within 1 month of baseline
  • Intrinsic QRS duration ≥ 130 ms within 1 month prior to baseline
  • Left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline
  • Left ventricular end diastolic dimension (LVEDD) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline
  • Willing to provide written informed consent
  • Are expected to survive for 6 month of study participation
  • Able to tolerate an urgent thoracotomy
  • Able to tolerate < 1 mg dexamethasone sodium phosphate (steroid)

Exclusion Criteria:

  • Having self-terminating or interminable AF
  • Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
  • Post-heart transplant (patients on heart transplant list for the first time are not excluded)
  • Having mechanical right heart valve
  • Having an existing CRT or atrial therapy device(s)
  • Being enrolled in any concurrent drug and/or device study which would confound the results of this trial
  • Having primary valvular disease and indicated for valve repair or replacement
  • Having a previous AV node ablation
  • Being on a Type I or Type III anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias
  • Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01233648
0601113
Not Provided
University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: David S. Schwartzman, MD University of Pittsburgh
University of Pittsburgh
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP